FDA.report

proGAV 2.0®

Primary DI
04041906140205
Brand
proGAV 2.0®
Company
Christoph Miethke GmbH & Co. KG
Model
FX343T
Catalog number
FX343T
Device description
PROGAV 2.0 WITH SA10 A.BURRHOLE RESERV.
Published
2015-11-11
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
JXGShunt, central nervous system and components

Product Code Classifications

CodeDeviceSpecialtyClass
JXGShunt, Central Nervous System And ComponentsNeurology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04041906140205PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04041906140205040419061402054041906140205

GMDN Terms

TermDefinition
Ventriculo-peritoneal/atrial shunt valveA sterile implantable device intended to function as part of a ventriculoperitoneal or ventriculoatrial shunt to regulate the pressure and flow level of cerebrospinal fluid (CSF) from the brain to the peritoneum/heart right atrium in the management of increased intracranial pressure (e.g., caused by hydrocephalus). It consists of a mechanical valve with catheter connections and is made of plastic and silicone materials. It typically opens at a pre-set pressure and may be non-invasively adjusted using a dedicated programmer.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)282-9000GUDID.BBMUS_Service@bbraun.com

Regulatory Flags

DUNS number
343189676
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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